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An Exploratory Study of 18F-Labeled Hydroxyphenethylguanidines in Heart Failure Patients

NCT02669563 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2017-02-27

No results posted yet for this study

Summary

The main goal of this study is to test two new radioactive drugs, 4-\[18F\]fluoro-meta-hydroxyphenethylguanidine (\[18F\]4F-MHPG) and 3-\[18F\]fluoro-para-hydroxyphenethylguanidine (\[18F\]3F-PHPG) in human subjects with congestive heart failure.

Evaluations of these imaging agents will include their uptake in heart, lungs and liver, their metabolic breakdown in blood, and their kinetics in the heart. Based on these studies, the better of the two drugs will be chosen for further studies in patients with heart disease. After the better compound is chosen, additional measures of its imaging properties, metabolism and pharmacokinetics will be done in subjects with heart failure.

Conditions

Interventions

DRUG

[18F]4F-MHPG

IV injection of \[18F\]4F-MHPG

DRUG

[18F]3F-PHPG

IV injection of \[18F\]3F-PHPG

DRUG

[13N]ammonia

IV injection of \[13N\]ammonia

DRUG

[11C]HED

IV injection of \[11C\]HED

Sponsors & Collaborators

Principal Investigators

  • David M Raffel, PhD · University of Michigan

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-31
Primary Completion
2016-08-31
Completion
2016-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02669563 on ClinicalTrials.gov